标准摘要
[中文适用范围]： 本文件规定了对专业用途体外诊断 (IVD) 仪器制造商提供的信息的要求。 本文件也适用于与 IVD 仪器一起用于专业用途的仪器和设备。 本文件也适用于配件。 本文件不适用于： a) 仪器保养或维修说明； b) IVD试剂，包括校准品和用于控制试剂的控制材料； c) 用于自检的IVD仪器。 [外文原描述]： This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This document can also be applicable to accessories. This document does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments for self-testing.
英文名称In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use